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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05267522




Registration number
NCT05267522
Ethics application status
Date submitted
2/02/2022
Date registered
4/03/2022

Titles & IDs
Public title
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Scientific title
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
Secondary ID [1] 0 0
204327
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Hyperlipidemias 0 0
Physical Inactivity 0 0
Diet, Healthy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Egg diet
Other interventions - Egg-free Diet
Other interventions - Control Diet

Experimental: Egg Diet - Egg diet, contains 2 eggs per day and limits saturated fat to 6% of energy intake. Cholesterol intake is 600mg/day. Protein and carbohydrate levels will be maintained at 20% and 40% of energy intake, respectively. This diet will be followed for 5 weeks.

Active comparator: Egg-free Diet - Egg-free diet, limits cholesterol to 300 mg/day (no eggs) with saturated fat intake at 12% of energy intake. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks.

Active comparator: Control Diet - Comparator diet based on the average Australian diet, limited to 1 egg per week, with saturated fat intake at 12% of energy intake. Cholesterol intake is 600 mg/day. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks.


Other interventions: Egg diet
30% fat \[6% saturated fat\], 20% protein, 40% carbohydrate, 600 mg cholesterol

Other interventions: Egg-free Diet
30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 300 mg cholesterol

Other interventions: Control Diet
30% fat \[12% saturated fat\], 25% protein, 40% carbohydrate, 600 mg cholesterol
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [2] 0 0
5 weeks
Primary outcome [3] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [3] 0 0
10 weeks
Primary outcome [4] 0 0
Low-density lipoprotein cholesterol (LDL-C)
Timepoint [4] 0 0
15 weeks
Secondary outcome [1] 0 0
Blood lipid profiling
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Blood lipid profiling
Timepoint [2] 0 0
5 weeks
Secondary outcome [3] 0 0
Blood lipid profiling
Timepoint [3] 0 0
10 weeks
Secondary outcome [4] 0 0
Blood lipid profiling
Timepoint [4] 0 0
15 weeks
Secondary outcome [5] 0 0
Fasting glucose
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Fasting glucose
Timepoint [6] 0 0
5 weeks
Secondary outcome [7] 0 0
Fasting glucose
Timepoint [7] 0 0
10 weeks
Secondary outcome [8] 0 0
Fasting glucose
Timepoint [8] 0 0
15 weeks
Secondary outcome [9] 0 0
Physical activity levels
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Physical activity levels
Timepoint [10] 0 0
5 weeks
Secondary outcome [11] 0 0
Physical activity levels
Timepoint [11] 0 0
10 weeks
Secondary outcome [12] 0 0
Physical activity levels
Timepoint [12] 0 0
15 weeks
Secondary outcome [13] 0 0
Waist circumference
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Waist circumference
Timepoint [14] 0 0
5 weeks
Secondary outcome [15] 0 0
Waist circumference
Timepoint [15] 0 0
10 weeks
Secondary outcome [16] 0 0
Waist circumference
Timepoint [16] 0 0
15 weeks
Secondary outcome [17] 0 0
Blood Pressure
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Blood Pressure
Timepoint [18] 0 0
5 weeks
Secondary outcome [19] 0 0
Blood Pressure
Timepoint [19] 0 0
10 weeks
Secondary outcome [20] 0 0
Blood Pressure
Timepoint [20] 0 0
15 weeks
Secondary outcome [21] 0 0
Dietary saturated fat intake
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Dietary saturated fat intake
Timepoint [22] 0 0
5 weeks
Secondary outcome [23] 0 0
Dietary saturated fat intake
Timepoint [23] 0 0
10 weeks
Secondary outcome [24] 0 0
Dietary saturated fat intake
Timepoint [24] 0 0
15 weeks
Secondary outcome [25] 0 0
Dietary cholesterol intake
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Dietary cholesterol intake
Timepoint [26] 0 0
5 weeks
Secondary outcome [27] 0 0
Dietary cholesterol intake
Timepoint [27] 0 0
10 weeks
Secondary outcome [28] 0 0
Dietary cholesterol intake
Timepoint [28] 0 0
15 weeks
Secondary outcome [29] 0 0
Dietary Energy intake
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Dietary Energy intake
Timepoint [30] 0 0
5 weeks
Secondary outcome [31] 0 0
Dietary Energy intake
Timepoint [31] 0 0
10 weeks
Secondary outcome [32] 0 0
Dietary Energy intake
Timepoint [32] 0 0
15 weeks
Secondary outcome [33] 0 0
Dietary Macronutrients
Timepoint [33] 0 0
Baseline
Secondary outcome [34] 0 0
Dietary Macronutrients
Timepoint [34] 0 0
5 weeks
Secondary outcome [35] 0 0
Dietary Macronutrients
Timepoint [35] 0 0
10 weeks
Secondary outcome [36] 0 0
Dietary Macronutrients
Timepoint [36] 0 0
15 weeks
Secondary outcome [37] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [37] 0 0
Baseline
Secondary outcome [38] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [38] 0 0
5 weeks
Secondary outcome [39] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [39] 0 0
10 weeks
Secondary outcome [40] 0 0
Dietary Lutein+Zeaxanthin
Timepoint [40] 0 0
15 weeks
Secondary outcome [41] 0 0
Sleep
Timepoint [41] 0 0
Baseline
Secondary outcome [42] 0 0
Sleep
Timepoint [42] 0 0
5 weeks
Secondary outcome [43] 0 0
Sleep
Timepoint [43] 0 0
10 weeks
Secondary outcome [44] 0 0
Sleep
Timepoint [44] 0 0
15 weeks

Eligibility
Key inclusion criteria
* Male or female, aged 18 - 60 years
* Blood LDL-C <3.5 mmol/L (measured at screening using an automated analyser (Cholestech LDX System).
* Non-smoker (or other nicotine products) (minimum 6 months).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have diagnosed cardiovascular disease (including uncontrolled high blood pressure) or a chronic disease, including Type-1 or -2 diabetes, kidney or liver disease, gastrointestinal disorders requiring medical nutrition therapy (e.g., Crohn's disease, irritable bowel, coeliac disease) or any other condition that may have an impact on study outcomes.
* Have allergies or strong aversion to eggs or other components of the test foods (diets are not suitable for vegetarians).
* Consume more than 5 eggs per week in the month prior to beginning the trial.
* Participant has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week.
* Have changed medication or supplementation that might affect study outcomes in the last 3 months.
* Take vitamin, mineral, herbal supplementation, or medications that may have an impact on study outcomes.
* Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study.
* Are pregnant or breastfeeding.
* Show unwillingness to be randomized to either experimental group.
* Failure to satisfy the investigator regarding suitability to participate for any other reason.
* Are unwilling or unable to provide written informed consent.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2023
Sample size
Target
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia Clinical Trial Facility - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Egg Board
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan D Buckley, PhD
Address 0 0
University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05267522